A Multiplexed Diagnostic Platform for Point-of-Care Pathogen Detection

Regan, J F ; Letant, S E ; Adams, K L ; Mahnke, R C ; Nguyen, N T ; Dzenitis, J M ; Hindson, B J ; Hadley, D R ; Makarewicz, T J ; Henderer, B D ; Breneman, J W ; Tammero, L F ; Ortiz, J I ; Derlet, R W ; Cohen, S ; Colston, W W ; McBride, M T ; Birch, J M

关键词: ADENOVIRUS;    DETECTION;    DISEASES;    INFECTIOUS DISEASES;    INFLUENZA;    MEDICAL ESTABLISHMENTS;    MICROSPHERES;    PATHOGENS;    PERFORMANCE;    SCREENS;    SENSITIVITY;    SPECIFICITY;    STRAINS;   

DOI  :  10.2172/926006
RP-ID  :  LLNL-TR-400998
PID  :  OSTI ID: 926006
Others  :  TRN: US200807%%554

学科分类：生物科学（综合）

美国|英语

来源: SciTech Connect

【 摘 要 】

We developed an automated point-of-care diagnostic instrument that is capable of analyzing nasal swab samples for the presence of respiratory diseases. This robust instrument, called FluIDx, performs autonomous multiplexed RT-PCR reactions that are analyzed by microsphere xMAP technology. We evaluated the performance of FluIDx, in comparison rapid tests specific for influenza and respiratory syncytial virus, in a clinical study performed at the UC Davis Medical Center. The clinical study included samples positive for RSV (n = 71), influenza A (n = 16), influenza B (n = 4), adenovirus (n = 5), parainfluenza virus (n = 2), and 44 negative samples, according to a composite reference method. FluIDx and the rapid tests detected 85.9% and 62.0% of the RSV positive samples, respectively. Similar sensitivities were recorded for the influenza B samples; whereas the influenza A samples were poorly detected, likely due to the utilization of an influenza A signature that did not accurately match currently circulating influenza A strains. Data for all pathogens were compiled and indicate that FluIDx is more sensitive than the rapid tests, detecting 74.2% (95% C.I. of 64.7-81.9%) of the positive samples in comparison to 53.6% (95% C.I. of 43.7-63.2%) for the rapid tests. The higher sensitivity of FluIDx was partially offset by a lower specificity, 77.3% versus 100.0%. Overall, these data suggest automated flow-through PCR-based instruments that perform multiplexed assays can successfully screen clinical samples for infectious diseases.